Benzonatate 200 mg
- Product NDC
- 25000-003
- 11-digit product format
- 250000003
- Labeler code
- 25000
- Product ID
- 25000-003_8668f10d-45dc-4248-88ac-6e8c5d576435
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate 200 mg
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA220298
- Marketing category
- ANDA
- Marketing start
- 2026-04-10
- Substance
- BENZONATATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benzonatate 200 mg
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZONATATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5P4DHS6ENR |
| Rxcui | 197397, 283417 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25000-003-03 | Benzonatate 200 mg | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | | 4 |
| 25000-003-08 | Benzonatate 200 mg | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | | 4 |
| 25000-003-12 | Benzonatate 200 mg | 500 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 500 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 25000-003-03 | 25000000303 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-003-03) | 2026-04-10 | No | No | Current |
| 25000-003-08 | 25000000308 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-003-08) | 2026-04-10 | No | No | Current |
| 25000-003-12 | 25000000312 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-003-12) | 2026-04-10 | No | No | Current |